Overview
FDA Calendar tracks upcoming Food and Drug Administration events and decisions for biotech and pharmaceutical companies. These events include PDUFA dates (drug approval deadlines), advisory committee meetings, and clinical trial result releases. FDA decisions are major binary catalysts that can cause significant price movement.
Event Types
| Event Type | Description | Impact Level |
|---|---|---|
| PDUFA Date | FDA deadline to approve or reject a drug application | Very High |
| AdCom Meeting | Advisory committee meeting to review drug data | High |
| Phase 3 Results | Late-stage clinical trial data release | High |
| Phase 2 Results | Mid-stage clinical trial results | Moderate |
| NDA/BLA Filing | New drug application filing date | Moderate |
| CRL Response | Complete Response Letter deadline | High |
Data Columns
| Column | Description |
|---|---|
| Symbol | Stock ticker of the biotech/pharma company |
| Company | Company name |
| Event Date | Scheduled date of the FDA event |
| Event Type | Type of FDA event (PDUFA, AdCom, etc.) |
| Drug Name | Name of the drug or therapy under review |
| Indication | Disease or condition the drug treats |
| Status | Current status of the application |
How to Use
- ●Review the calendar regularly for upcoming FDA catalysts
- ●PDUFA dates are the highest-impact events for binary price movement
- ●Cross-reference with the stock's technical setup for timing context
- ●Be aware that FDA events create extreme volatility in both directions
- ●Use filters to focus on specific event types or date ranges
Warning
FDA events are binary catalysts with extreme outcome uncertainty. Approval or rejection can cause 30-80% moves in either direction. This data is for awareness and research purposes only.
Combining with Other Tools
- ●Check Options Lab volatility term structure to see how much move the options market is pricing for the FDA date
- ●Cross-reference with Options Flow to see if smart money is positioning bullish or bearish ahead of the event
- ●Use Fundamental Ranking to assess the company's overall financial health beyond the single catalyst
- ●Monitor Volume Alerts for unusual volume spikes as the FDA date approaches
This platform provides data and analysis tools for educational and informational purposes only. Nothing on this platform constitutes financial advice, investment recommendations, or solicitation to buy or sell any securities. Always conduct your own research and consult with a qualified financial advisor before making investment decisions.